# K001986: Surgitron Iec II

- Pathway: 510(k) (Traditional)
- Applicant: Ellman Intl., Inc.
- Decided: Sep 27, 2000 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K034004: Diego RF Powered Dissector and Drill System Console (2004), 50 descendants of its own
- K072302: Entellus Medical RS-Series System (2008), 44 descendants of its own
- K081542: Modification to Entellus Medical RS-Series System (2008), 42 descendants of its own
- K093007: Entellus Medical Balloon Device (2010), 41 descendants of its own
- K102003: Xpress Balloon Device (2010), 36 descendants of its own

Source page: https://510kreport.com/device/K001986
Methodology: https://510kreport.com/methodology